Back to resultsModulation of Gut Microbiota to Enhance Health and Immunity
Primary Purpose
Gut Microbiota, COVID-19 Vaccine
Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Microbiome immunity formula
Active placebo
Sponsored by
About this trial
This is an interventional prevention trial for Gut Microbiota
Eligibility Criteria
Substudy 1
Inclusion Criteria:
- Age 18 years - below 65 years
- A confirmed diagnosis of type 2 DM for ≥ 3 months with stable control (i.e. no change in DM medications in recent 2 months)
- Written informed consents obtained
Exclusion Criteria:
- Known history of confirmed COVID-19 infection
- Known active sepsis or active malignancy
Known increased infection risk due to underlying immunosuppressed state which includes:
- Prior organ or hematopoietic stem cell transplant
- Neutropenia with absolute neutrophil count (ANC) <500 cells/ul at the time of study inclusion
- Known HIV infection with CD4 <200 cells/ul at the time of study inclusion
- On concomitant immunosuppressants or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months
- Known history or active infective endocarditis
- On peritoneal dialysis or haemodialysis
- Documented pregnancy
Substudy 2
Inclusion Criteria:
- Age 65 years and above
- Written informed consents obtained
Exclusion Criteria:
- Known history of confirmed COVID-19 infection
- Known active sepsis or active malignancy
Known increased infection risk due to underlying immunosuppressed state which includes:
- Prior organ or hematopoietic stem cell transplant
- Neutropenia with absolute neutrophil count (ANC) <500 cells/ul at the time of study inclusion
- Known HIV infection with CD4 <200 cells/ul at the time of study inclusion
- On concomitant immunosuppressants, chemotherapies or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months
- Known history or active infective endocarditis
- On peritoneal dialysis or haemodialysis
- Known active malignancy
- Known terminal illness with life expectancy less than 3 months
Sites / Locations
- Prince of Wales Hospital, Shatin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active arm
Placebo arm
Arm Description
Subject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks.
Subject will be instructed to take active placebo daily for a total of 12 weeks.
Outcomes
Primary Outcome Measures
Adverse events/Serious adverse events
Proportion of patients who presented with new symptoms/diseases which exerted unfavourable impacts on subjects. Serious adverse events are those adverse clinical events that resulted in hospital admission and/or death
Secondary Outcome Measures
Immunogenicity of the COVID-19 vaccine
Measured by serum neutralization assay against pseudo virus and live virus, and IgM and IgG against receptor-binding domain [RBD] and S1
Change in gut microbiome
Measured the gut microbiome changes by metagenomic sequencing and metabolite profiling by targeted and/or untargeted metabolites profiling
Changes in plasma inflammatory cytokines
Measured the inflammatory cytokines (CRP or ESR) in blood result
Restoration of gut dysbiosis
It is defined as improvement in (i) gut microbiome composition and diversity; (ii) functional potential (i.e., MetaCyc pathway abundances); and (iii) proliferation of beneficial bacteria genus (i.e., bifidobacteria, eubacterium, roseburia and other short-chain fatty acids producers
Number of unscheduled hospitalisation and clinic visits
Number of unscheduled hospitalisation and clinic visits
Changes of quality of life
Measured the score of EQ-5D-5L which measure the health-related quality of life
Changes in glycaemic control
Measured by HbA1c
Full Information
NCT ID
NCT04884776
First Posted
April 29, 2021
Last Updated
December 27, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04884776
Brief Title
Modulation of Gut Microbiota to Enhance Health and Immunity
Official Title
Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The novel coronavirus infection (COVID-19) caused by the SARS-CoV-2 virus is now a pandemic and has culminated major morbidity and mortality globally. Studies have shown that patients with underlying type 2 diabetes mellitus (DM), obesity, old age and hypertension had a higher risk of developing severe COVID-19 infection and mortality related to COVID-19.Emerging evidence has shown that gut microbiota plays an important role in the pathogenesis of COVID-19.
Detailed Description
HYPOTHESIS We hypothesize that modulating the gut microbiota with a microbiome immunity formula can rebalance the gut microbiota in populations at risk of infection, like, patients with type 2 DM and elderlies and can lower the number of hospitalisation and reduce side effects associated with COVID-19 vaccination.
AIM We aim to evaluate the efficacy of modulating gut microbiota with a microbiome immunity formula in vulnerable subjects (patients with underlying type 2 DM and elderlies) in improving immune functions, reducing adverse events associated with COVID-19 vaccinations and reducing hospitalisation in susceptible individuals during the COVID-19 pandemic.
STUDY DESIGN This is a double-blinded, randomized, active-placebo controlled study comparing a microbiome immunity formula and placebo in enhancing immunity and reducing hospitalisation within one year. Except two kinds of subjects (Substudy 1: Patients with Type 2 DM and Substudy 2: Elderly individual) will be included in respective substudy, all other methodologies are the same. In each substudy, at least half of the recruited subjects will plan to receive COVID-19 vaccination and start to take the study products after vaccination. Recruited subjects will be randomised to receive a microbiome immunity formula or active placebo for 3 months, with another 9 months follow-up after completion of study products.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Microbiota, COVID-19 Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
453 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active arm
Arm Type
Active Comparator
Arm Description
Subject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Subject will be instructed to take active placebo daily for a total of 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Microbiome immunity formula
Intervention Description
Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)
Intervention Type
Dietary Supplement
Intervention Name(s)
Active placebo
Intervention Description
Active placebo contains active vitamin
Primary Outcome Measure Information:
Title
Adverse events/Serious adverse events
Description
Proportion of patients who presented with new symptoms/diseases which exerted unfavourable impacts on subjects. Serious adverse events are those adverse clinical events that resulted in hospital admission and/or death
Time Frame
within 6 months
Secondary Outcome Measure Information:
Title
Immunogenicity of the COVID-19 vaccine
Description
Measured by serum neutralization assay against pseudo virus and live virus, and IgM and IgG against receptor-binding domain [RBD] and S1
Time Frame
3 months and 6 months
Title
Change in gut microbiome
Description
Measured the gut microbiome changes by metagenomic sequencing and metabolite profiling by targeted and/or untargeted metabolites profiling
Time Frame
1, 3, 6, and 12 months
Title
Changes in plasma inflammatory cytokines
Description
Measured the inflammatory cytokines (CRP or ESR) in blood result
Time Frame
3 months and 6 months
Title
Restoration of gut dysbiosis
Description
It is defined as improvement in (i) gut microbiome composition and diversity; (ii) functional potential (i.e., MetaCyc pathway abundances); and (iii) proliferation of beneficial bacteria genus (i.e., bifidobacteria, eubacterium, roseburia and other short-chain fatty acids producers
Time Frame
1, 3, 6 and 12 months
Title
Number of unscheduled hospitalisation and clinic visits
Description
Number of unscheduled hospitalisation and clinic visits
Time Frame
1, 3, 6, and 12 months
Title
Changes of quality of life
Description
Measured the score of EQ-5D-5L which measure the health-related quality of life
Time Frame
1, 3, 6, and 12 months
Title
Changes in glycaemic control
Description
Measured by HbA1c
Time Frame
1, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Substudy 1
Inclusion Criteria:
Age 18 years - below 65 years
A confirmed diagnosis of type 2 DM for ≥ 3 months with stable control (i.e. no change in DM medications in recent 2 months)
Written informed consents obtained
Exclusion Criteria:
Known history of confirmed COVID-19 infection
Known active sepsis or active malignancy
Known increased infection risk due to underlying immunosuppressed state which includes:
Prior organ or hematopoietic stem cell transplant
Neutropenia with absolute neutrophil count (ANC) <500 cells/ul at the time of study inclusion
Known HIV infection with CD4 <200 cells/ul at the time of study inclusion
On concomitant immunosuppressants or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months
Known history or active infective endocarditis
On peritoneal dialysis or haemodialysis
Documented pregnancy
Substudy 2
Inclusion Criteria:
Age 65 years and above
Written informed consents obtained
Exclusion Criteria:
Known history of confirmed COVID-19 infection
Known active sepsis or active malignancy
Known increased infection risk due to underlying immunosuppressed state which includes:
Prior organ or hematopoietic stem cell transplant
Neutropenia with absolute neutrophil count (ANC) <500 cells/ul at the time of study inclusion
Known HIV infection with CD4 <200 cells/ul at the time of study inclusion
On concomitant immunosuppressants, chemotherapies or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months
Known history or active infective endocarditis
On peritoneal dialysis or haemodialysis
Known active malignancy
Known terminal illness with life expectancy less than 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce WY Mak, FHKAM
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, Shatin
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Modulation of Gut Microbiota to Enhance Health and Immunity
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